A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer (AndroMETa-CRC)

September 16, 2026 updated by: AbbVie

An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with refractory metastatic colorectal cancer (mCRC).

Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 990 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally.

In this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine/tipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

990

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Antwerpen
      • Bonheiden, Antwerpen, Belgium, 2820
        • Recruiting
        • Imelda Ziekenhuis /ID# 279333
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • Universitair Ziekenhuis Antwerpen /ID# 279334
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
        • Recruiting
        • Institut Jules Bordet /ID# 279406
      • Brussels, Brussels Capital, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires UCL Saint-Luc /ID# 279335
      • Jette, Brussels Capital, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel /ID# 279535
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6280
        • Recruiting
        • Grand Hopital de Charleroi - Les Viviers /ID# 279336
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Recruiting
        • Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 280014
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • AZ Maria Middelares /ID# 280141
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • Universitair Ziekenhuis Leuven /ID# 279330
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • Recruiting
        • AZ-Delta. /ID# 279329
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100050
        • Recruiting
        • Beijing Friendship Hospital /ID# 279766
      • Beijing, Beijing Municipality, China, 100006
        • Recruiting
        • Beijing Hospital No. 2 /ID# 279666
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center /ID# 279670
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Guangxi Medical University Cancer Hospital /ID# 279707
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital - Tongji Medical College /ID# 283649
    • Jilin
      • Changchun, Jilin, China, 130033
        • Recruiting
        • China-Japan Union Hospital /ID# 279801
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The Fourth Affiliated Hospital of China Medical University /ID# 279799
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Recruiting
        • General Hospital Of Ningxia Medical University /ID# 279644
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Hospital /ID# 279705
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • First Affiliated Hospital of Shanxi Medical University /ID# 279665
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital Zhejiang University School Of Medicine /ID# 279874
  • Greece
      • Thessaloniki, Greece, 54639
        • Recruiting
        • Theagenio Cancer Hospital /ID# 279129
      • Thessaloniki, Greece, 57001
        • Recruiting
        • Interbalkan Medical Center Of Thessaloniki /ID# 279288
    • Attica
      • Athens, Attica, Greece, 11525
        • Recruiting
        • Athens Medical Center - Psychikon Branch /ID# 279134
      • Nea Kifissia, Attica, Greece, 14564
        • Recruiting
        • General Oncology Hospital of Kifisia Agioi Anargyroi /ID# 279133
  • Japan
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East /ID# 279917
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Recruiting
        • National Hospital Organization Shikoku Cancer Center /ID# 280224
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Recruiting
        • Kobe City Medical Center General Hospital /ID# 280233
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • Recruiting
        • St Marianna University School Of Medicine /ID# 279902
    • Osaka
      • Osaka, Osaka, Japan, 5418567
        • Recruiting
        • Osaka International Cancer Institute /ID# 281810
    • Tokyo
      • Koto-ku, Tokyo, Japan, 135-8550
        • Recruiting
        • The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 282329
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Unidade Local de Saude de Santa Maria /ID# 279624
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 279702
    • Braga District
      • Guimarães, Braga District, Portugal, 4835-044
        • Recruiting
        • Unidade Local de Saude do Alto Ave, EPE /ID# 279703
    • Lisbon District
      • Loures, Lisbon District, Portugal, 2674-514
        • Recruiting
        • Unidade Local de Saude de Loures-Odivelas /ID# 279636
    • Setúbal District
      • Almada, Setúbal District, Portugal, 2805-267
        • Recruiting
        • Unidade Local de Saude de Almada-Seixal, EPE /ID# 279637
  • South Korea
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, South Korea, 49201
        • Recruiting
        • Dong-A University Medical Center /ID# 279610
    • Gyeonggido
      • Incheon, Gyeonggido, South Korea, 21565
        • Recruiting
        • Gachon University Gil Medical Center /ID# 279592
      • Seongnam, Gyeonggido, South Korea, 13496
        • Recruiting
        • CHA Bundang Medical Center /ID# 279589
      • Suwon, Gyeonggido, South Korea, 16247
        • Recruiting
        • The Catholic University Of Korea St. Vincent's Hospital /ID# 279675
    • Jeonranamdo
      • Hwasun-gun, Jeonranamdo, South Korea, 58128
        • Recruiting
        • Chonnam National University Hwasun Hospital /ID# 279787
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital /ID# 282730
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Recruiting
        • Asan Medical Center /ID# 282732
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau /ID# 279642
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall de Hebron /ID# 279651
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre /ID# 279659
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz /ID# 279664
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Maranon /ID# 279650
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia /ID# 279645
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet /ID# 279653
  • Taiwan
      • Kaohsiung City, Taiwan, 824
        • Recruiting
        • E-Da Cancer Hospital /ID# 279745
      • New Taipei City, Taiwan, 235
        • Recruiting
        • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 279708
      • Tainan, Taiwan, 71004
        • Recruiting
        • Chi Mei Medical Center /ID# 279710
      • Taipei, Taiwan, 114
        • Recruiting
        • Tri-Service General Hospital - Neihu Branch /ID# 279768
      • Taipei, Taiwan, 116
        • Recruiting
        • Taipei Municipal Wan Fang Hospital /ID# 280285
    • Tainan
      • Taipei, Tainan, Taiwan, 110
        • Recruiting
        • Taipei Medical University Hospital /ID# 280607
  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Recruiting
        • City Of Hope - Phoenix /ID# 279450
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group - Springdale /ID# 279444
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center /ID# 279449
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Rocky Mountain Cancer Centers - Aurora /ID# 280112
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University School of Medicine /ID# 279373
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center /ID# 279325
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • City Of Hope - Atlanta /ID# 280017
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center /ID# 279365
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Lukes Hospital of Kansas City /ID# 279513
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816-4096
        • Recruiting
        • Astera Cancer Care /ID# 279532
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health Center for Advanced Medicine. /ID# 279590
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center /ID# 279322
    • Ohio
      • Cincinnati, Ohio, United States, 45252
        • Recruiting
        • Oncology Hematology Care - Blue Ash /ID# 280143
    • Oregon
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Compass Oncology - Rose Quarter /ID# 280127
    • Texas
      • Abilene, Texas, United States, 79606
        • Recruiting
        • Texas Oncology - Abilene - Antilley Road /ID# 280120
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Recruiting
        • Blue Ridge Cancer Care - Blacksburg /ID# 280115
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator.
  • Life expectancy >= 12 weeks per investigator assessment

Exclusion Criteria:

  • Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any Top-1 inhibitor ADC.
  • History of intolerance, allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil. This also includes patients with known rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
  • History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
  • History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ph 3: Telisotuzumab Adizutecan + Bevacizumab
Participants will receive telisotuzumab adizutecan + Bevacizumab as part of an approximately 36 months study duration.
Drug: Telisotuzumab adizutecan
Intravenous (IV)
Drug: Bevacizumab
Intravenous (IV)
Experimental: Ph 3: SOC Trifluridine and Tipiracil + Bevacizumab
Participants will receive standard of care (SOC) trifluridine and tipiracil +Bevacizumab as part of an an approximately 36 months study duration.
Drug: Bevacizumab
Intravenous (IV)
Drug: Trifluridine/Tipiracil
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to Approximately 15 Months
Best overall response of confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Up to Approximately 15 Months
Phase 3: Overall Survival (OS)
Time Frame: Up to Approximately 36 Months
OS is defined as the time from date of randomization to the event of death from any cause.
Up to Approximately 36 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 3: Disease Control (DC) as assessed by BICR:
Time Frame: Up to Approximately 24 Months
DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, v1.1
Up to Approximately 24 Months
Phase 3: Overall Survival (OS) in Participants With c-Met Subgroup >= 10%, 3+
Time Frame: Up to Approximately 36 Months
OS is defined as the time from date of randomization to the event of death from any cause.
Up to Approximately 36 Months
Phase 3: Overall Survival (OS) in Participants With c-Met Subgroup < 10%, 3+
Time Frame: Up to Approximately 36 Months
OS is defined as the time from date of randomization to the event of death from any cause.
Up to Approximately 36 Months
Phase 3: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to Approximately 24 Months
PFS is defined as the time from date of randomization to the first occurrence of radiographic progression based on RECIST v1.1 or death from any cause, whichever occurs earlier.
Up to Approximately 24 Months
Phase 3: Duration Of Response (DoR) as assessed by BICR
Time Frame: Up to Approximately 24 Months
DoR defined as time from the date of initial response of confirmed CR or PR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first. DoR is defined for subjects with confirmed CR/PR.
Up to Approximately 24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M24-560
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-521712-19-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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